EPA’s illegal human experiments could break Nuremberg Code

[Geee]

Washington Times:

The Obama Environmental Protection Agency (EPA) says no law empowers any judge to stop it from conducting illegal scientific experiments on seniors, children and the sick.

That astounding assertion will be tested Friday, when a federal district court in Alexandria decides whether it has jurisdiction to hear claims made by the American Tradition Institute that EPA researchers are exposing unwary and genetically susceptible senior citizens to air pollutants the agency says can cause a variety of serious cardiac and respiratory problems, including sudden death.

Although the lawsuit only addresses ongoing, purportedly illegal experimentation being carried out at an EPA laboratory on the Chapel Hill campus of the University of North Carolina School of Medicine, EPA researchers and grantees have carried out dozens of similarly shocking experiments over the past 10 years at UNC and other schools, including Rutgers University, the University of Michigan, University of Rochester, University of Southern California and University of Washington.

During that time at those university laboratories, EPA-employed or -funded researchers have intentionally exposed a variety of people to concentrated levels of different air pollutants, including particulate matter (soot and dust), diesel exhaust, ozone and chlorine gas — the latter substance more recognized as a World War I-era chemical weapon than as an outdoor air pollutant.

[Valin]

@Geee

 

EXCUSE ME!

Am I the only one who has some problems with this? This has a real Teutonic feel to it.

[Draggingtree]

HHS.gov

U.S. Department of Health & Human Services

Federal Policy for the Protection of Human Subjects ('Common Rule')

 

 

The current U.S. system of protection for human research subjects is heavily influenced by the

Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report outlines the basic ethical principles in research involving human subjects. In 1981, with this report as foundational background, HHS and the Food and Drug Administration revised, and made as compatible as possible under their respective statutory authorities, their existing human subjects regulations.

The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below. The HHS regulations,

45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. Each agency includes in its chapter of the Code of Federal Regulations [CFR] section numbers and language that are identical to those of the HHS codification at 45 CFR part 46, subpart A. For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency. The head of that department/agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule. If an institution seeks guidance on implementation of the Common Rule and other applicable federal regulations, the institution should contact the department/agency conducting or supporting the research.

The list below displays the agencies and departments that have signed onto the Common Rule and their CFR numbers. Hyperlinks are to areas of a department or agency Web site that have been suggested to HHS as entry points for those interested in human subject protection activities of the department or agency.

 

 

 

In addition, the Central Intelligence Agency must comply with all subparts of 45 CFR part 46 under Executive Order 12333. The Department of Homeland Security, created after issuance of the Common Rule, has chosen to apply all subparts of 45 CFR part 46 to its human research activities.

Several non-HHS federal departments and agencies have additional regulations in place for research involving special populations or for human subjects research in general. The federal department/agency that conducts or supports research retains final authority for determining whether an institution has complied with its regulations for the protection of human subjects. If HHS receives an allegation or indication of noncompliance related to human subject research that is conducted or supported solely by a Common Rule department/agency other than HHS, HHS will refer the matter to that department/agency for review and action as appropriate.

Investigators are encouraged to review the regulations of the funding agency to determine whether additional regulations apply. Also, many agencies have not adopted subparts B, C, or D and grantees of those agencies are not necessarily bound by them. Grantees should consult their funding agency for guidance.

[Draggingtree]

HHS.gov

 

U.S. Department of Health & Human Services

 

The Belmont Report

 

 

Office of the Secretary

 

Ethical Principles and Guidelines for the Protection of Human

Subjects of Research

 

The National Commission for the Protection of Human Subjects

of Biomedical and Behavioral Research

 

April 18, 1979

 

 

 

 

AGENCY: Department of Health, Education, and Welfare.

 

ACTION: Notice of Report for Public Comment.

 

SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.

 

The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

 

Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public comment on this recommendation.

 

 

National Commission for the Protection of Human Subjects

of Biomedical and Behavioral Research

 

 

Members of the Commission

Table of Contents

 

 

 

Ethical Principles and Guidelines for Research Involving Human Subjects

 

A. Boundaries Between Practice and Research

 

B. Basic Ethical Principles

 

1. Respect for Persons

 

2. Beneficence

 

3. Justice

 

C. Applications

 

1. Informed Consent

 

2. Assessment of Risk and Benefits

 

3. Selection of Subjects